PUTRAJAYA, Jan 8 – Roche Pharmaceuticals, one of the world’s largest pharmaceutical companies, has confirmed Sarawak General Hospital as the site for a First-in-Human (FIH) clinical trial in Malaysia.
Roche is the first top multinational company to bring its FIH trials under a rheumatology indication to Malaysia — a testament to Malaysia’s growing clinical trial capabilities in Asia, and only within two years from the completion of Clinical Research Malaysia’s (CRM) Phase 1 Realisation Project (P1RP), which enabled the FIH ecosystem in the country.
The announcement was made during CRM’s Clinical Research Excellence in Early Phase and People Development event, officiated by Health Minister Dzulkefly Ahmad.
Following the announcement, Malaysia will be the seventh country included for this study and the first within the Asia Pacific region, joining along other global sites located in Europe and South Africa.
“Malaysia’s clinical trial ecosystem has developed rapidly with over 2,300 clinical research conducted since 2012. CRM, through its P1RP initiative, have overseen the development of the country’s early phase ecosystem, to enable safe and regulated conduct of early phase research especially FIH trials.
“Following the completion of P1RP in 2021, Malaysia has conducted one FIH and two First-in-Patient studies, with Roche’s study being the first FIH in Malaysia under a rheumatology indication,” said Dzulkefly.
The FIH trial is on a new experimental drug to treat patients with Systemic Lupus Erythematosus (SLE), an autoimmune condition that affects joints, skin, brain, lungs, kidneys, and blood vessels.
The study is led by consultant rheumatologist Dr Teh Cheng Lay, and will be conducted in Sarawak General Hospital’s (SGH) Clinical Research Centre, which is an accredited FIH facility under the National Pharmaceutical Regulatory Agency.
“SLE predominantly affects women aged between 15 and 50 years old, as the group makes up to 80 per cent of the over 10,000 people diagnosed with SLE in Malaysia. There is a need to explore new treatment options that provide minimal side effects, as many SLE patients develop other underlying health complications due to this chronic illness.
“Hence, we are excited to have Sarawak General Hospital selected among the other competing global institutions, in being a part of this study. I believe with our experience and resources, we would contribute to pertinent safety data of this experimental drug amongst the Asian population,” said Dr Teh.
“One aspect of concern for women with SLE is its potential impact on fertility and pregnancy. At Roche, women’s health is a priority for us, as we aim to develop tailored solutions to improve women’s quality of life, and also empower women to take charge of their wellbeing through education, early detection, and personalised care.
“Driven by our purpose in ‘Doing now what patients need next’, we trust that through collaboration, integrity, courage, and a passion for discovery, we are able to push the boundaries of what is possible, especially for patients, which is at the core of everything we do,” said Deepti Saraf, Roche Malaysia general manager.
To date in Malaysia, Roche has launched 33 late phase clinical trials in breast cancer, gastrointestinal cancer, hematology, diabetes, cardiovascular, rheumatology, and hepatocellular carcinoma. Since 2012, Roche have invested around RM190 million in clinical trials in Malaysia.
“Going a step further, we are thrilled that we are expanding our geographical footprint for the early phase FIH clinical trials in Malaysia. Working together with CRM and SGH’s Clinical Research Centre, we are especially committed to further strengthen clinical research and clinical trial capability here in the country.
“We are confident with the clinical research talent and infrastructure in the country and look forward to working with Dr Teh and her team to discover new modalities in treating SLE.
?With this monumental milestone, we also believe Malaysia is in a great place with its diverse population and capable clinical trial workforce to contribute to global health outcomes,” Deepti added.
